Helpful answers to common questions

Information about participating in this study.

Research Basics

What is a research study?
The goal of research is to learn new things in order to help groups of people in the future. Investigators learn things by following the same plan with a number of participants, so they do not usually make changes to the plan for individual research participants. You, as an individual, may or may not be helped by volunteering for a research study. This is not a clinical study and we do not provide medical treatment.
What is informed consent?
Before participating in a research study, researchers must provide participants with a description of the project’s methods and goals. what the study is about and what participants will be asked to do. Then, you must complete a form acknowledging that you have received and understand that information about the study and that you agree to participate.

Signing / completing the informed consent form is NOT like signing a contract; you can leave the study at any time, for any reason. You are also encouraged to ask questions at any time throughout the study.

Study Participation

What is the goal of this study?
The purpose of this study is to better understand development in infants and toddlers with dysgenesis or agenesis of the corpus callosum. Improved understanding of development over this period will improve clinical recommendations and treatment planning in the future.
Who can participate in this study?
Parents / primary caregivers of a child who is less than 36 months of age and who has received a clinical diagnosis of corpus callosum malformation via MRI, CT, or ultrasound. Dysgenesis of the corpus callosum includes complete and partial agenesis of the corpus callosum (ACC or AgCC) and hypoplasia of the corpus callosum. Caregivers must be 18 years or older and must be proficient in reading and speaking English.
What does this study involve?
Participation in this study requires you to complete several hours of online questionnaires and phone interviews, on up to five occasions over a 2.5-year period, regarding your child’s medical history and behavior, as well as your own behavior and family context.

You will also be asked to submit copies of your child’s brain scans (MRI, CT, or ultrasound) and radiology reports, which will be used solely to confirm the corpus callosum diagnosis required for study participation.

You will also be mailed a kit to contribute salivary samples for future extraction of salivary DNA. These samples will be stored by the Caltech team.

Some families enrolled in this study will be asked to participate in an additional phase of this research that includes visiting the University of Minnesota for an in-person developmental assessment. Travel expenses will be covered.

Who will see my data from this study?
We will make every effort to assure that your Personal Health Information (PHI) is kept extremely confidential. Efforts will be made to limit the use and disclosure of your personal information, including research study data and medical records, to people who have a need to review this information. Your information will not be shared without your permission or except required by law.
How much time will it take?
Caregivers will participate on up to 5 occasions when their child is between 6 and 36 months of age (around the ages of 6, 12, 18, 24, and 30/36 months).

At each visit, caregivers will complete questionnaires online (~2-3 hours) and will participate in phone-based interviews (~1-2 hours), which will take ~4-5 total hours per visit.

What if I miss one of the testing time-points?
If you miss one time-point, you can simply continue the study at the next time-point. However, you must complete at least 5 time-points (including the 30/36 month testing) in order to get the $50 completion bonus
What if I change my mind part way through the study?
You can choose to withdraw from the study at any time without penalty. You do not need to provide a reason for withdrawing from the study.
What if I don’t qualify for this study?
If you complete the online consent to participate and provide your contact information, with your permission, we will keep this basic demographic information about your family and may inform future studies of both current and future study opportunities related to ACC.
Will I receive research test results?
While we will be happy to talk to you about the scientific findings of our work, we will not be able to give you any clinical feedback. This means we cannot tell you how you or your child compares to other people/children on any of the measures. Most tests done on samples in research studies are only for research and have no clear meaning for health care.
What happens if I agree to participate, but I change my mind later?
If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. To withdraw from this study, you only need to let the experimenter or the principal investigator know. You can do this by calling them on the phone or by email. You will not be asked to explain your reasons. You may also ask to have your data removed from the study. You will not be asked to explain your reasons. Drs. Paul or Elison will contact you to confirm receipt and fulfillment of your request.

Risk & Benefits

How will this study help people with ACC?
Possible benefits from this research include establishing and extending our understanding of dysgenesis/agenesis of the corpus callosum during infancy and toddlerhood.

This understanding can be used to create more effective intervention techniques and supports for children and adults with DCC/ACC.

What are the risks of participating?
You will be asked questions about your child and your own personal history, medical history, feelings, thoughts, and behaviors. These questions may raise negative feelings and may be stressful.
Will it cost me anything to participate?
No, you do not have to pay anything to take part in the study.

If you are invited to the University of Minnesota for a direct behavioral assessment, all travel expenses will be paid.

Will I be compensated for my participation?
If you agree to take part in this research study, we will pay you $20 US for completing the testing at each time-point. If you complete at least 5 time-points, including the 30/36 month testing, you will receive an additional $50 US. (This does not include in-person testing in Minnesota.)